FDA-approved, for example:

• bipolar disorder
• fibromyalgia
• migraine prophylaxis
• neuropathic pain associated with diabetic peripheral neuropathy
• postherpetic neuralgia
• seizure disorder(s) including Dravet syndrome, treatment-resistant epilepsy associated with tuberous sclerosis complex (TSC), infantile spasms, Lennox-Gastaut syndrome (LGS), partial seizures, and primary generalized tonic-clonic seizures

Non-FDA-approved, for example:

• non-FDA-approved refractory epilepsy syndrome, refractory epilepsy, or refractory seizures

Note: The above lists may not include all FDA-approved and non-FDA-approved indications.

• All PA requests must include clinical diagnosis, drug name, dose, and frequency. 
• Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
• A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
• For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
• Additional criteria may apply depending upon diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

Aptiom

• Documentation of the following is required: 
  • diagnosis of epilepsy or a seizure disorder; and
  • member is ≥ four years of age; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • inadequate response or adverse reaction to any two anticonvulsants.

SmartPA: Claims for Aptiom will usually process at the pharmacy without a PA request if the member is ≥ four years of age, has a history of MassHealth medical claims for epilepsy/seizures, the prescriber is a neurologist, and the member has a history of paid MassHealth pharmacy claims for any two anticonvulsants. Claims for Aptiom will also usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims of the requested agent for at least 90 out of the last 120 days of the requested agent and if the member has a history of MassHealth medical claims for epilepsy/seizures.^†

Briviact

• Documentation of the following is required:
  • diagnosis of epilepsy or a seizure disorder; and
  • prescriber is a neurologist or consult notes from neurology office are provided; and
  • inadequate response or adverse reaction to any two anticonvulsants; and
  • for the tablet formulation, requested quantity is ≤ two tablets/day.

SmartPA: Claims for Briviact (within the quantity limit of two tablets/day for the tablet formulation) will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for epilepsy/seizures, the prescriber is a neurologist, and if the member has a history of paid MassHealth pharmacy claims for any two anticonvulsants. Claims for Briviact (within the quantity limit of two tablets/day for the tablet formulation) will also usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims of the requested agent for at least 90 out of the last 120 days of the requested agent and if the member has a history of MassHealth medical claims for epilepsy/seizures.^†

Concomitant gabapentin and pregabalin Polypharmacy (a history of at least one paid MassHealth pharmacy claim for the other agent within the last 30 days)

• For all requests, individual drug PA criteria must be met first where applicable.
• Documentation of the following is required:
  • appropriate diagnosis for gabapentin; and
  • appropriate diagnosis for pregabalin; and
  • complete treatment plan; and
  • clinical rationale for the concomitant use of gabapentin and pregabalin; and
  • one of the following:
    • inadequate response to the maximum daily dose of each agent as monotherapy; or
    • inadequate response to the maximum tolerated dose of each agent as monotherapy and requested doses are less than the doses at which the adverse drug reaction or side effect occurred; and
  • inadequate response or adverse reaction to two or contraindication to all other alternatives for the requested indication.

Diacomit

• Documentation of the following is required:
  • diagnosis of Dravet syndrome; and
  • member is ≥ two years of age; and
  • prescriber is a neurologist or consult notes from neurology office are provided; and
  • requested medication will be used in combination with clobazam; and
  • inadequate response or adverse reaction to any two anticonvulsants.

Diacomit, Epidiolex, and Fintepla for non-FDA approved refractory epilepsy syndrome, refractory epilepsy, or refractory seizures

• Documentation of the following is required:
  • appropriate diagnosis; and
  • prescriber is a neurologist or consult notes from neurology office are provided; and
  • for Diacomit and Fintepla, member is ≥ two years of age; and
  • inadequate response or adverse reaction to three anticonvulsants; and
  • member will be using the requested agent as adjunctive therapy.

diazepam rectal gel > 5 kits (10 syringes)/30 days, Nayzilam > 10 units/30 days, and Valtoco > 10 units/30 days

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • for diazepam rectal gel, medical necessity for greater than 5 kits (10 syringes)/30 days; or 
    • for Nayzilam and Valtoco, medical necessity for greater than 10 units/30 days; and
  • prescriber is a neurologist or consult notes from a neurology office are provided.

Elepsia XR

• Documentation of the following is required:
  • diagnosis of epilepsy or a seizure disorder; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • medical necessity for the requested agent instead of the levetiracetam extended-release formulation available without PA.

Epidiolex

• Documentation of the following is required for the diagnosis of Dravet syndrome or Lennox-Gastaut syndrome:
  • medical records supporting the diagnosis; and
  • prescriber is a neurologist or consult notes from neurology office are provided; and
  • member will be using the requested agent as adjunctive therapy; and
  • inadequate response or adverse reaction to any two anticonvulsants.
• Documentation of the following is required for the diagnosis of seizures associated with tuberous scleroris complex (TSC):
  • appropriate diagnosis; and
  • prescriber is a neurologist or consult notes from neurology office are provided; and
  • member will be using the requested agent as adjunctive therapy.

Eprontia

• Documentation of the following is required:
  • one of the following:
    • diagnosis of epilepsy or a seizure disorder; or
    • diagnosis of migraine prophylaxis; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • one of the following:
    • member has severe dysphagia and is currently utilizing only formulations that can easily be swallowed; or
    • member utilizes tube feeding (G-tube/J-tube) and is unable to utilize crushed tablets; or
    • member is ≤ 16 years of age and requested dose cannot be obtained from topiramate formulations available without PA; or
    • medical necessity for the requested formulation instead of other topiramate formulations available without PA.

everolimus tablets for oral suspension and everolimus 2.5 mg, 5 mg, 7.5 mg, 10 mg

• Documentation of the following is required: 
  • diagnosis of treatment-resistant epilepsy associated with tuberous sclerosis complex (TSC); and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • inadequate response to combination therapy with at least two anticonvulsants or contraindication to all other anticonvulsants; and
  • requested agent will be used as adjunctive therapy with at least one anticonvulsant agent; and
  • requested quantity is ≤ one unit/day.

Fintepla

• Documentation of the following is required:
  • diagnosis of Dravet syndrome or Lennox-Gastaut Syndrome; and
  • member is ≥ two years of age; and
  • prescriber is a neurologist or consult notes from neurology office are provided; and
  • member will be using the requested agent as adjunctive therapy; and
  • inadequate response or adverse reaction to any two anticonvulsants; and
  • one of the following:
    • if not used in combination with stiripentol, requested quantity is ≤ 11.9 mL/day (26 mg/day); or
    • if used in combination with stiripentol and clobazam, requested quantity is ≤ 7.8 mL/day (17 mg/day).

Fycompa

• Documentation of the following is required: 
  • diagnosis of epilepsy or a seizure disorder; and
  • member is ≥ four years of age; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • inadequate response or adverse reaction to any two anticonvulsants.

SmartPA: Claims for Fycompa will usually process at the pharmacy without a PA request if the member is ≥ four years of age, has a history of MassHealth medical claims for epilepsy/seizures, the prescriber is a neurologist, and the member has a history of paid MassHealth pharmacy claims for any two anticonvulsants. Claims for Fycompa will also usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims of the requested agent for at least 90 out of the last 120 days and if the member has a history of MassHealth medical claims for epilepsy/seizures.^†

gabapentin capsule, solution, tablet > 3,600 mg/day

• Documentation of the following is required:
  • appropriate diagnosis; and
  • clinical rationale for exceeding the maximum daily dose limit.

• Documentation of the following is required for the diagnosis of bipolar disorder:
  • appropriate diagnosis; and
  • prescriber is a psychiatrist or consult notes from a psychiatry office are provided; and
  • medical necessity for the extended-release formulation instead of the immediate-release formulation. 
• Documentation of the following is required for the diagnosis of epilepsy or a seizure disorder:
  • appropriate diagnosis; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • medical necessity for the extended-release formulation instead of the immediate-release formulation.

lamotrigine tablet starter kit

• Documentation of the following is required for the diagnosis of bipolar disorder:
  • appropriate diagnosis; and
  • prescriber is a psychiatrist or consult notes from a psychiatry office are provided; and
  • medical necessity for use instead of lamotrigine tablets.
• Documentation of the following is required for the diagnosis of epilepsy or a seizure disorder:
  • appropriate diagnosis; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • medical necessity for use instead of lamotrigine tablets.

lamotrigine ODT and lamotrigine ODT starter kit 

• Documentation of the following is required for the diagnosis of bipolar disorder:
  • appropriate diagnosis; and
  • prescriber is a psychiatrist or consult notes from a psychiatry office are provided; and
  • medical necessity for the requested formulation instead of formulation available without PA; and
  • inadequate response or adverse reaction to lamotrigine dispersible tablets. 
• Documentation of the following is required for the diagnosis of epilepsy or a seizure disorder:
  • appropriate diagnosis; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • medical necessity for the requested formulation instead of formulation available without PA; and
  • inadequate response or adverse reaction to lamotrigine dispersible tablets.

Oxtellar XR

• Documentation of the following is required:
  • diagnosis of epilepsy or a seizure disorder; and
  • member is ≥ six years of age; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • medical necessity for this branded extended-release formulation instead of both of the following: oxcarbazepine tablets, oxcarbazepine suspension; and
  • one of the following:
    • member has been stabilized on oxcarbazepine (any formulation); or
    • inadequate response or adverse reaction to any two anticonvulsants.

pregabalin

• Documentation of the following is required:
  • one of the following appropriate diagnoses:
    • epilepsy/seizure disorder; or
    • fibromyalgia; or
    • neuropathic pain associated with diabetic peripheral neuropathy; or
    • neuropathic pain associated with spinal cord injury; or
    • post-herpetic neuralgia; and
  • one of the following:
    • requested dose is ≤ 600 mg/day; or
    • clinical rationale for exceeding the maximum daily dose limit.

rufinamide

• Documentation of the following is required:
  • diagnosis of Lennox-Gastaut Syndrome, epilepsy, or a seizure disorder; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • inadequate response or adverse reaction to any two anticonvulsants.

SmartPA: Claims for rufinamide will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for epilepsy/seizures, the prescriber is a neurologist, and the member has a history of paid MassHealth pharmacy claims for any two anticonvulsants. Claims for rufinamide will also usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims of the requested agent for at least 90 out of the last 120 days and if the member has a history of MassHealth medical claims for epilepsy/seizures.^†  

Spritam

• Documentation of the following is required:  
  • diagnosis of myoclonic seizures, epilepsy, or a seizure disorder; and
  • medical necessity for this oral tablet for suspension formulation instead of levetiracetam solution; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • one of the following:
    • diagnosis of myoclonic seizures and member is ≥ 12 years of age; or
    • diagnosis of epilepsy or a seizure disorder and all of the following:
      • member is ≥ four years of age; and
      • one of the following:
        • member has been stabilized on levetiracetam (any formulation); or
        • inadequate response or adverse reaction to any two anticonvulsants.   

Sympazan

• Documentation of the following is required:
  • diagnosis of Lennox-Gastaut Syndrome, epilepsy, or a seizure disorder; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • member will be using the requested agent as adjunctive therapy; and
  • member is ≥ two years of age; and
  • medical necessity for this branded film formulation instead of both of the following: clobazam tablets and clobazam suspension; and
  • inadequate response or adverse reaction to any two anticonvulsants.

SmartPA: Claims for clobazam suspension and tablet will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims of the requested agent for at least 90 out of the last 120 days and if the member has a history of MassHealth medical claims for epilepsy/seizures.†

tiagabine

• Documentation of the following is required:  
  • diagnosis of epilepsy or a seizure disorder; and
  • member is ≥ 12 years of age; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • member will be using the requested agent as adjunctive therapy; and
  • inadequate response or adverse reaction to any two anticonvulsants.   

topiramate extended-release capsules (generic Trokendi XR)

• Documentation of the following is required for the diagnosis of Lennox-Gastaut Syndrome, epilepsy, or a seizure disorder:  
  • appropriate diagnosis; and
  • member is ≥ six years of age; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • medical necessity for use instead of topiramate extended-release capsules (generic Qudexy XR); and
  • inadequate response or adverse reaction to any two anticonvulsants.

• Documentation of the following is required for the diagnosis of migraine prophylaxis:
  • appropriate diagnosis; and
  • member is ≥ 12 years of age; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • medical necessity for use instead of topiramate extended-release capsules (generic Qudexy XR); and 
  • inadequate response or adverse reaction to topiramate tablets; and
  • inadequate response or adverse reaction to one or contraindication to all of the following prophylactic treatments:
    • beta-blocker; or
    • calcium channel blocker; or
    • divalproex or valproic acid; or
    • tricyclic antidepressant.

SmartPA: Claims for topiramate extended-release capsules (generic Trokendi XR) will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims of the requested agent for at least 90 out of the last 120 days and if the member has a history of MassHealth medical claims for epilepsy/seizures.†

vigabatrin

• Documentation of the following is required for the diagnosis of epilepsy or a seizure disorder:
  • appropriate diagnosis; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • member is ≥ two years of age; and
  • member will be using the requested agent as adjunctive therapy; and
  • inadequate response or adverse reaction to any two anticonvulsants. 
• Documentation of the following is required for the diagnosis of infantile spasms:
  • appropriate diagnosis; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • member is < two years of age. 

Mood Stabilizer Polypharmacy (overlapping pharmacy claims for three or more mood stabilizers [agents considered to be used only for seizure diagnoses are not included] for at least 60 days within a 90-day period) for members < 18 years of age

• For all requests, individual drug PA criteria must be met first where applicable.
• Documentation of the following is required for members with seizure diagnosis only:
  • appropriate diagnosis (seizure) without comorbid condition.

• Documentation of the following is required for members with psychiatric diagnoses, with or without seizure diagnosis:
  • one of the following:
    • member had a recent psychiatric hospitalization (within the last three months); or
    • member has a history of severe risk of harm to self or others; or
  • all of the following:
    • appropriate psychiatric diagnoses; and
    • treatment plan including names of current mood stabilizers and corresponding diagnoses; and
    • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided; and
    • one of the following:
      • cross-titration/taper of mood stabilizer therapy; or
      • inadequate response or adverse reaction to two monotherapy trials and/or multiple combination therapy trials as clinically appropriate.

• Documentation of the following is required for members with a diagnoses in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain), with or without seizure diagnosis:
  • one of the following:
    • member had a recent psychiatric hospitalization (within the last three months); or
    • member has a history of severe risk of harm to self or others; or
  • all of the following:
    • appropriate diagnosis in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain); and
    • treatment plan including names of current mood stabilizers and corresponding diagnoses; and
    • documentation that other clinically appropriate therapies have been tried and failed; therefore, multiple mood stabilizers are needed.

• Documentation of the following is required for members with a psychiatric diagnosis and comorbid diagnosis in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain), with or without seizure diagnosis:
  • one of the following:
    • member had a recent psychiatric hospitalization (within the last three months); or
    • member has a history of severe risk of harm to self or others; or
  • all of the following:
    • psychiatric diagnosis and diagnosis in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain); and
    • treatment plan including names of current mood stabilizers and corresponding diagnoses; and
    • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided; and
    • documentation that other clinically relevant therapies have been tried and failed; therefore, multiple mood stabilizers are needed; and
    • one of the following:
      • cross-titration/taper of mood stabilizer therapy; or
      • inadequate response or adverse reaction to two monotherapy trials and/or multiple combination therapy trials as clinically appropriate.

Mood Stabilizer for members < six years of age (agents considered to be used only for seizure diagnoses are not included)

• For all requests, individual drug PA criteria must be met first where applicable.
• Documentation of the following is required:
  • one of the following:
    • member  had a recent psychiatric hospitalization (within the last three months); or
    • member has a history of severe risk of harm to self or others; or
    • member has a seizure diagnosis only; or
  • all of the following:
    • appropriate diagnosis; and
    • treatment plan including names of current behavioral health medications and corresponding indications; and
    • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided.

SmartPA: Claims for mood stabilizers or benzodiazepines will usually process at the pharmacy without a PA request if the member is < six years of age, has a history of MassHealth medical claims for seizure, and does not have a history of MassHealth medical claims for psychiatric diagnoses and/or other diagnoses in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain).^†